Dr. Daniel Knott, Chief of Facial Plastic and Reconstructive Surgery at UCSF recently participated in developing the following consensus statement on facial paralysis (Bell’s Palsy) during the COVID-19 pandemic published by the American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS).
It has taken decades to amass the evidence base defining best practice in management of idiopathic facial paralysis (hereafter Bell’s palsy), and new questions have arisen during the COVID-19 pandemic. This document synthesizes best available evidence and expert opinion regarding management of Bell’s palsy during the COVID-19 pandemic, with particular emphasis on the role of corticosteroids. The work group’s evidence-informed consensus recommendations are provided at the end of this document, subject to modification with the emergence of new data and findings.
Bell’s palsy was reported in 6 of nearly 34,000 patients enrolled in clinical trials of the 2 current COVID-19 vaccines created by Pfizer-BioNTech1 and Moderna2 and approved by the Federal Drug Agency (FDA) under emergency use authorization (EUA). Similarly, the influenza literature had initially documented rare instances of Bell’s palsy associated with vaccination, but subsequent pooling of data found no significant increase in rate of Bell’s palsy among those vaccinated.3,4 At this time, there is insufficient evidence to conclude the existence of a causal relationship between vaccination against COVID-19 and Bell’s palsy. The FDA will continue surveillance for cases of Bell’s palsy as vaccination efforts continue.
While evidence supports use of corticosteroids for treatment of Bell’s palsy, an important question for clinicians to consider is whether this treatment standard should be modified in the setting of the COVID-19 pandemic. Bell’s palsy guidelines from the American Academy of Otolaryngology–Head and Neck Surgery Foundation5 and the American Academy of Neurology6 recommend use of corticosteroids to improve recovery of facial function in afflicted patients. Corticosteroids improve the speed and completeness of facial nerve recovery in placebo-controlled trials where therapy was initiated within 72 hours of onset.
There was concern for the general use of corticosteroids at the infancy of the COVID-19 pandemic. Data from MERS, SARS, and influenza experiences suggested initial caution with the use of corticosteroids during the COVID-19 era, as corticosteroid treatment was thought to have the potential to reduce immune response and worsen patient outcomes.7 Thus far in the case of COVID-19, critically ill patients and hospitalized patients who require supplemental oxygen demonstrate benefit from corticosteroids (specifically dexamethasone). However, corticosteroids are currently not recommended for use in less severe manifestations of COVID-19.8
Corticosteroids and COVID vaccine efficacy. The impact of short-term corticosteroids and SARS-CoV-2 vaccination efficacy has not been studied. In clinical trials, the Pfizer-BioNTech vaccine achieved 52% efficacy after the first injection and 95% efficacy 7 days after the second dose was administered.9 Whether corticosteroid administration would alter this efficacy is unknown. Patients were excluded from trial participation if systemic corticosteroids (≥20 mg/day of prednisone or equivalent) were received for ≥14 days from 28 days prior to enrollment to Visit 3 for Phase 2/3 participants (Pfizer-BioNTech protocol10) or within 6 months prior to screening (Moderna protocol11). Pfizer-BioNTech and Moderna vaccine guidance states that immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response.12,13 The Infectious Diseases Society of America notes that immunocompromised persons receiving high-dose corticosteroids (20 mg per dose or >2 mg/kg/day daily prednisone or equivalent) may have an attenuated immune response to the vaccine.14
Corticosteroids and vaccine safety. The two current FDA EUA COVID vaccines by Pfizer-BioNTech and Moderna are mRNA vaccines that recruit cellular machinery to synthesize the spike protein that allows viral entry. Immune response to this protein confers protection from COVID-19. The Centers for Disease Control and Prevention (CDC) states that all inactivated vaccines can be administered safely to persons with altered immunocompetence and that short-term corticosteroid therapy (<14 days) is usually not a contraindication to administration of live vaccines.15 We acknowledge, the Pfizer-BioNTech and Moderna vaccines are neither live vaccines nor inactivated vaccines and introduce immunity through a different mechanism.
Data are not currently available to establish vaccine safety and efficacy in immunocompromised patients or those who are taking immunosuppressive medications. While immunocompromising conditions, including use of immunocompromising medications, are not contraindications to receiving either the Pfizer-BioNTech or Moderna vaccines, the CDC notes that immunocompromised individuals “should be counseled about the unknown vaccine safety profile and effectiveness.”16 Antibody testing is not recommended to assess for immunity to COVID-19 following mRNA COVID-19 vaccination.16
Recommendations
Below is recommended guidance for management of Bell’s palsy during the COVID pandemic:
• Vaccination against SARS-CoV-2 is vital to curbing the COVID-19 pandemic. Timely access to and administration of the vaccines should remain as over-arching guidance.
• In patients who develop Bell’s palsy shortly after vaccination: Corticosteroid therapy +/- anti-herpes viral therapy (acyclovir, valacyclovir) is recommended, according to previously established guidelines. Patients should be counselled that the effect of corticosteroids on the safety and efficacy of Pfizer-BioNTech or Moderna vaccines is currently unknown. However, immunocompromising conditions and the use of immunocompromising medications are not contraindications to vaccination with either of these vaccines.
• In unvaccinated patients who develop Bell’s palsy: Corticosteroid therapy +/- anti-herpes viral therapy (acyclovir, valacyclovir) is recommended, according to previously established guidelines. Patients may proceed with vaccination while being treated for Bell’s palsy with corticosteroids versus delaying vaccination until after completion of corticosteroid course, in discussion with their healthcare provider.
• As in all cases of facial paralysis, the broad underlying differential diagnosis should be considered, as per clinical practice guideline recommendations.
------------------------
1 FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine. U.S. Food and Drug Administration website. Accessed January 11, 2021. https://www.fda.gov/media/144245/download
2 FDA Briefing Document, Moderna COVID-19 Vaccine. U.S. Food and Drug Administration website. Accessed January 11, 2021. https://www.fda.gov/media/144434/download
3 Stowe J, Andrews N, Wise L, Miller E. Bell's palsy and parenteral inactivated influenza vaccine. Hum Vaccin. 2006;2(3):110-112.
4 Committee to Review Adverse Effects of Vaccines; Institute of Medicine; Chapter 6: Influenza. In: Stratton K, Ford A, Rusch E, et al., eds. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press. 2011:293-420. Accessed January 17, 2021. https://www.ncbi.nlm.nih.gov/books/NBK190013/
5 Baugh R, Basura G, Ishii L, et al. Clinical Practice Guideline: Bell’s palsy. Otolaryngol Head Neck Surg. 2013;149(3)(suppl): S1-S27.
6 Gronseth GS, Paduga R. Evidence-based guideline update: steroids and antivirals for Bell palsy: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2012;79:2209-2213
7 Prescott HC, Rice TW. Corticosteroids in COVID-19 ARDS: Evidence and Hope during the Pandemic. JAMA - J Am Med Assoc. 2020;324(13):1292-1295.
8 Therapeutic Management of Patients with COVID-19. NIH COVID-19 Treatment Guidelines website. Updated December 3, 2020. Accessed January 9, 2021. https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/
9 Polack FP, Thomas SJ, Kitchin N, et al; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615.
10 A Phase 1/2/3, Placebo-controlled Randomized, Observer-blind, Dose-finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. Pfizer website. Accessed January 17, 2021.
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf
11 A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older. Moderna website. Accessed January 17, 2021. https://www.modernatx.com/sites/default/files/content_documents/Final%20mRNA-1273-P301%20Protocol%20Amendment%206%20-%2023Dec2020.pdf
12 Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Accessed January 16, 2021. http://labeling.pfizer.com/ShowLabeling.aspx?id=14471
13 Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Accessed January 16, 2021. https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf
14 Vaccines FAQ. COVID Real-Time Learning Network website. Updated January 15, 2021. Accessed January 17, 2021.
https://www.idsociety.org/covid-19-real-time-learning-network/vaccines/vaccines-information--faq/#efficacy
15 Vaccine Recommendations and Guidelines of the ACIP. Centers of Disease Control and Prevention website. Accessed January 11, 2021.
https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html
16 Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Centers for Disease Control and Prevention website. Updated January 6, 2021. Accessed January 16, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
About this Statement:
The aim is to guide physicians on the treatment of 1) patients who develop Bell’s palsy shortly after vaccination, and 2) unvaccinated patients who develop Bell’s palsy during the COVID-19 pandemic. The statement was coordinated by C. W. David Chang, MD, Co-chair of the AAO-HNS Patient Quality and Safety Improvement Committee. Members of six AAO-HNS committees and two infectious disease specialists participated:
• Patient Safety Quality and Improvement Committee
• Outcomes Research and Evidence-Based Medicine Committee
• Infectious Disease Committee
• Otology and Neurotology Education Committee
• Plastic and Reconstructive Surgery Committee
• Facial Plastic and Reconstructive Surgery Education Committee
• Emily Stoneman, MD, (University of Michigan) and Christelle Ilboudo, MD, (University of Missouri)
